Recall Z-1161-2008 ยท MSX System, Network And Communication, Physiological Monitors
GE Healthcare
S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.
| Date | Jun 24, 2008 (initiated Dec 13, 2007) |
| Status | Terminated |
| Reason | Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm. |
| Root cause | Device Design |
| Action | Consignees were notified via a Medical Device Correction letter on 12/13/07. The letter explained the circumstances in which the "connection to monitor loss" alarm would not display, if a monitor was disconnected. The letter also included an attachment entitled "How to ensure a 'Connection to monitor lost' alarm on iCentral." For additional information, contact 1-800-558-7044. |
| Quantity | 2146 |
| Distribution | Worldwide Distribution including USA states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, PA, SC, TN, TX, VA, VT, WA and WI; and countries of Algeria, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052972 | DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE Healthcare, Dec 29, 2005 |